¿ Abgenix Inc., of Fremont, Calif., launched new versions of XenoMouse mice that produce fully human monoclonal antibodies that contain both lambda and kappa light chains. Other transgenic mouse technologies in the commercial sector make human antibodies that contain only kappa light chains, it said. Abgenix expects these strains of mice, making both human IgG kappa and human IgG lambda monoclonal antibodies, to expand significantly the number and diversity of XenoMouse-derived antibody product candidates for its collaborators and for itself. The purpose of adding the lambda light chain genes to XenoMouse strains of mice is to capture and to mimic more completely the full repertoire of the human antibody response.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, successfully completed its first systemic toxicology study of multiple injections of Reolysin in animals. The study examined the effects of 28 consecutive days of intravenous administration of Reolysin in Sprague-Dawley rats. The results demonstrated that there were no significant adverse clinical outcomes as a result of the administration of the reovirus at any of the dose levels tested.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said its European marketing partner, MediGene AG, of Martinsried, Germany, submitted a marketing authorization application for Leuprogel One-Month Depot, leuprolide acetate for the treatment of prostate cancer, to the German regulatory authority as a reference member state under a mutual recognition process. If approval is obtained in the reference state, MediGene would submit a modified MAA to specific concerned member states in the European Union for marketing approval in other countries.
¿ Celera Genomics Group, of Rockville, Md., and Paradigm Genetics Inc., of Research Triangle Park, N.C., announced an alliance in agriculture genomics. Paradigm will acquire Celera¿s AgGen plant genomics and genotyping business and become the exclusive marketing partner for Celera services to the plant-based agriculture industries. Paradigm¿s new business unit will be called ParaGen. Celera will receive 422,459 shares of Paradigm common stock that were valued at slightly more than $2 million, based on Monday¿s closing Paradigm price of $4.87. Celera also will share future service revenue with Paradigm. Terms were not disclosed.
¿ Consensus Pharmaceuticals Inc., of Medford, Mass., appointed John Schulte as CEO. Most recently, Schulte was president and CEO of Somnus Medical Technologies, which was recently acquired by the Gyrus Group plc. Prior to Somnus, Schulte was the president of Genzyme Surgical Products, a division of Genzyme Corp. Consensus is a closely held company using proprietary technologies to validate targets and identify leads. The company¿s technologies are uniquely suited to proteases, kinases and G protein-coupled receptors.
¿ Esperion Therapeutics Inc., of Ann Arbor, Mich., initiated a multiple-dose, multicenter Phase II study of its ApoA-I Milano product candidate (ETC-216) in patients with acute coronary syndromes. The purpose of the trial is to provide evidence that ETC-216 is effective in regressing coronary artherosclerosis by measuring changes in plaque size utilizing intravascular ultrasound. The trial is a randomized, double-blind study that will evaluate the efficacy and safety of ETC-216 at two different levels of intravenous infusions, compared to placebo. The study will evaluate 50 patients with ACS who are scheduled to undergo coronary angiography and/or angioplasty. The primary endpoint is the effect of ETC-216 on plaque size of one targeted coronary artery.
¿ Eukarion Inc., of Bedford, Mass., is joining forces with Proteome Systems Inc., of Sydney, Australia, and the Buck Institute for Age Research in a collaborative program on the proteomics of aging. The program is focused on mitochondrial oxidative stress and the role of mitochondrial dysfunction in aging and degenerative neurological disease. Eukarion will provide synthetic pharmacological compounds that augment natural antioxidant pathways for studies on longevity in mice.
¿ Laboratory Corporation of America Holdings, of Salt Lake City, and Myriad Genetics Inc., of Burlington, N.C., entered a partnership to make Myriad¿s predictive medicine products broadly available to primary care physicians throughout the United States. LabCorp becomes Myriad¿s exclusive sales and distribution partner, marketing the products through its 600-person U.S. sales force. Myriad will continue to market its products to oncologists through its own 85-person oncology sales force. All of Myriad¿s predictive medicine products are included in this agreement, including the company¿s three cancer predictive products and its hypertension product.
¿ Large Scale Biology Corp., of Vacaville, Calif., and Plant Bioscience Ltd., of Norwich, UK, said LSBC has expanded its field of use to include all higher plants including the commercially relevant monocots for which LSBC already has developed a series of Geneware vectors for cereal crops. Under the terms of the original agreement announced in June, LSBC exclusively licensed certain viral-derived gene silencing and overexpression technologies developed at The Sainsbury Laboratory in Norwich. LSBC also has been licensed exclusively by PBL to employ certain other viral-derived technologies for gene silencing and enhanced gene expression developed at North Carolina State University.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, discovered a new role in the immune system for a known enzyme and plans to develop drugs that could be used to block inflammation and potentially even prevent organ transplant rejection. The function of the target, designated LG293, was uncovered through the company¿s industrialized gene knockout program in which mice lacking specific genes are studied to uncover favorable medical profiles for developing new drugs. The company said this is the first time that enzyme has been implicated in regulating the immune system.
¿ MicroDose Technologies Inc., of Monmouth Junction, N.J., successfully completed a Phase I study evaluating the pulmonary delivery of human insulin, being conducted with joint venture partner Elan Corp. plc, of Dublin, Ireland. It is the first clinical study to evaluate Elan¿s dry powder formulations of insulin in combination with MicroDose¿s novel dry powder inhaler. Initial results indicate significantly improved bioavailability compared with competitive products in development, the companies said. The product is targeted at the treatment of both Type I and Type II diabetes to replace subcutaneous insulin injections.
¿ New Brunswick Scientific Co. Inc., of Edison, N.J., reported that 47 percent-owned DGI BioTechnologies Inc. received a milestone payment from partner Novo Nordisk A/S, of Copenhagen, Denmark. The milestone was the first resulting from the DGI-Novo collaboration to find small-molecule mimics for insulin, and was achieved using DGI¿s integrated drug discovery platform Diogenesis to identify and simplify the interaction between insulin and its receptor. New Brunswick Scientific also reported the launch by DGI of Proteome Panning, a novel proteome mining technology that has led to the identification of DGI-3, a new anticancer target.
¿ Orchid BioSciences Inc., of Princeton, N.J., launched its 96-well genotyping kit for its high-throughput genotyping customers and collaborators. The kit incorporates Orchid¿s SNP-IT genotyping technology in a standard 96-well plate format that can be read visually or using the standard readers found in most life sciences laboratories. Through a recent agreement, Invitrogen Corp., of San Diego, is the exclusive provider of 96-well SNP genotyping kits using Orchid¿s technology.
¿ Plexxikon Inc., of Berkeley, Calif., and Scynexis Chemistry & Automation Inc., of Research Triangle Park, N.C., signed an agreement under which Plexxikon will access Scynexis¿ MedChem-Factory technology as part of a rapid ramp-up of Plexxikon¿s chemistry programs. The agreement provides Plexxikon with dedicated chemistry processes using technology from chemists experienced in automation and high-throughput discovery chemistry.
¿ Replicon Technologies Inc., of Birmingham, Ala., and the University of Alabama at Birmingham in the Dec. 1, 2001, issue of Cancer Research reported encouraging results of preclinical studies with replicon technology to treat cancer. Resulted showed the ability of replicons to kill human glioma cells implanted in laboratory mice. Replicons were shown to shrink tumor mass and also substantially prolong animal survival by statistically significant levels of 60 percent or more.
¿ Salmedix Inc., of San Diego, completed a Phase I trial of SDX-101, an oral drug to treat chronic lymphocytic leukemia and other hematologic malignancies. SDX-101 is designed to selectively kill cancer cells by inducing natural cell death pathways. The 36-subject study was a pharmacokinetic, safety and tolerability trial of SDX-101. SDX-101 was found to be safe and well tolerated in the study of an older volunteer population designed to match the demographics of patients with the disease.
¿ The Senate, in a procedural vote Monday, rejected by a 94-1 vote Sen. Sam Brownback¿s (R-Kan.) amendment to place a six-month moratorium on human and therapeutic cloning. The amendment was connected to a controversial energy measure that would permit oil drilling in Alaska. Legislation to ban human and therapeutic cloning already has passed in the House (HR2505).
¿ Unigene Laboratories Inc., of Fairfield, N.J., was notified by the New Jersey Economic Development Authority that it was approved to sell to already identified third parties a portion of its total available tax benefits. Unigene should receive in excess of $800,000 from the sale of these benefits during the next month under a state program that allows emerging technology and biotechnology companies to sell available New Jersey net operating loss carryovers and research and development credits.
¿ Xcyte Therapies Inc., of Seattle, withdrew its initial public offering, citing market conditions. The company filed for its IPO, estimated at about $86.2 million, in December 2000. Xcyte develops therapeutic products that generate immune responses to treat cancer and infectious diseases. (See BioWorld Today, Dec. 27, 2000.)
¿ Zycos Inc., of Lexington, Mass., completed enrollment for a multinational Phase II trial for its lead product, ZYC101a, in patients with human papillomavirus-associated cervical dysplasia. ZYC101a is a DNA-based therapeutic designed to generate an immune response against HPV. The trial is a double-blind, placebo-controlled study of ZYC101 in high-grade cervical dysplasia patients in the United States and Europe. Zycos is studying various parameters including immune response and clinical efficacy.